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促红细胞生成素治疗脑低灌注卒中患者后行多孔骨钻颅间直接血管重建术的随机对照试验

Transdural Revascularization by Multiple Burrhole After Erythropoietin in Stroke Patients With Cerebral Hypoperfusion: A Randomized Controlled Trial.

机构信息

Department of Neurology (J.M.H., M.H.C., G.H.P., S.-J.L., J.S.L), Ajou University School of Medicine, Ajou University Medical Center, Suwon, South Korea.

Department of Biomedical Sciences, Ajou University Graduate School of Medicine, Suwon, South Korea (H.S.S.).

出版信息

Stroke. 2022 Sep;53(9):2739-2748. doi: 10.1161/STROKEAHA.122.038650. Epub 2022 May 17.

DOI:10.1161/STROKEAHA.122.038650
PMID:35579016
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9389942/
Abstract

BACKGROUND

In patients with acute symptomatic stroke, reinforcement of transdural angiogenesis using multiple burr hole (MBH) procedures after EPO (erythropoietin) treatment has rarely been addressed. We aimed to investigate the efficacy and safety of cranial MBH procedures under local anesthesia for augmenting transdural revascularization after EPO treatment in patients with stroke with perfusion impairments.

METHODS

This prospective, randomized, blinded-end point trial recruited patients with acute ischemic stroke with a perfusion impairment of grade ≥2 within 14 days of symptom onset, steno-occlusive mechanisms on imaging examinations, and absence of transdural collaterals on transfemoral cerebral angiography. Patients were randomly assigned to receive MBH + EPO or MBH alone. The primary and secondary outcomes were revascularization success (trans-hemispheric and trans-burr hole) at 6 months and adverse events, respectively.

RESULTS

We evaluated 42 of the 44 targeted patients, with 2 patients lost to follow-up. The combined and MBH-only (n=21 each) groups showed no differences in demographic characteristics and baseline perfusion parameters. Significantly, more cases of trans-hemispheric (19/21 [90.5%] versus 12/21 [57.1%]) and trans-burr hole (42/58 [72.4%] versus 30/58 [51.7%]) revascularization and significant improvements in perfusion parameters were observed in the combined group relative to the MBH-only group. No differences in treatment-related complications were observed between groups. Even after adjustment for potential covariates, EPO usage was an independent factor of successful hemispheric revascularization in this study (odds ratio, 6.41 [95% CI, 1.08-38.02]).

CONCLUSIONS

The combination of MBH and EPO is safe and feasible for reinforcing transdural revascularization in acute steno-occlusive patients with perfusion impairments.

REGISTRATION

URL: https://www.

CLINICALTRIALS

gov; Unique identifier: NCT02603406.

摘要

背景

在有症状的急性卒中患者中,使用多次颅骨钻孔(MBH)手术强化 EPO(促红细胞生成素)治疗后的硬脑膜血管生成的情况很少被报道。我们旨在研究局部麻醉下颅骨 MBH 手术在有灌注损伤的卒中患者中增强 EPO 治疗后的硬脑膜再血管化的疗效和安全性。

方法

这项前瞻性、随机、盲终点试验招募了在症状发作后 14 天内存在灌注损伤程度为 2 级及以上、影像学检查显示狭窄闭塞机制和经股脑血管造影显示无硬脑膜侧支的急性缺血性卒中患者。患者被随机分配接受 MBH+EPO 或 MBH 单独治疗。主要和次要结局分别为 6 个月时的再血管化成功率(跨半球和跨颅骨钻孔)和不良事件。

结果

我们评估了 44 名目标患者中的 42 名,其中 2 名患者失访。联合组和仅 MBH 组(每组 21 名)在人口统计学特征和基线灌注参数方面没有差异。重要的是,联合组的跨半球(19/21[90.5%]比 12/21[57.1%])和跨颅骨钻孔(42/58[72.4%]比 30/58[51.7%])再血管化的病例更多,并且灌注参数有显著改善。两组之间未观察到治疗相关并发症的差异。即使在校正潜在协变量后,在这项研究中,EPO 的使用也是半球再血管化成功的独立因素(优势比,6.41[95%CI,1.08-38.02])。

结论

MBH 和 EPO 的联合应用是安全可行的,可用于增强有灌注损伤的急性狭窄闭塞患者的硬脑膜再血管化。

注册

网址:https://www.

临床试验

gov;独特标识符:NCT02603406。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fe8/9389942/57a9a48f7cd6/str-53-2739-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fe8/9389942/4dc6b11c678a/str-53-2739-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fe8/9389942/781151f9dcec/str-53-2739-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fe8/9389942/57a9a48f7cd6/str-53-2739-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fe8/9389942/4dc6b11c678a/str-53-2739-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fe8/9389942/781151f9dcec/str-53-2739-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1fe8/9389942/57a9a48f7cd6/str-53-2739-g006.jpg

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